Orthoscan, Inc. recalls Ziehm Vision FD. Interventional fluoroscopic x-ray system

Recall date

August 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0576-2025

FDA classification

Class II

Brand / firm

Orthoscan, Inc.

Sold / distributed

U.S. (including Puerto Rico).

Why it was recalled

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ziehm Vision FD. Interventional fluoroscopic x-ray system